Long-term outcome of patients with frequently recurrent non-muscle-invasive bladder carcinoma treated with one perioperative plus four weekly instillations of mitomycin C followed by monthly bacillus Calmette-Guérin (BCG) or alternating BCG and interferon-α2b instillations: prospective randomised FinnBladder-4 study.

BACKGROUND: Recurrent TaT1 non-muscle-invasive bladder cancer (NMIBC) patients should be treated with immediate instillation of chemotherapy after transurethral resection of bladder tumour followed by instillation therapy. OBJECTIVE: To present long-term results of a study exploring the effect of initial mitomycin C (MMC) instillations followed by two types of immunotherapy for patients with frequently recurring NMIBC. DESIGN, SETTING, AND PARTICIPANTS: Between 1992 and 1996, 236 patients with frequently recurring TaT1 grade 1-2 NMIBC were enrolled in the prospective randomised multicentre FinnBladder-4 study. INTERVENTION: One perioperative plus four weekly instillations of MMC followed by monthly bacillus Calmette-Guérin (BCG) or alternating BCG and interferon (IFN)-α2b instillations for up to 1 yr. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary end points were time to first recurrence and time to progression. Secondary end points were disease-specific mortality and overall survival. The principal statistical methods were the proportional subdistribution hazards model and Cox proportional hazards model plus cumulative incidence and Kaplan-Meier analyses. RESULTS AND LIMITATIONS: The median follow-up was 10.3 yr (maximum: 19.8 yr) in the MMC-BCG group and 8.6 yr (maximum: 19.8 yr) in the MMC-BCG/IFN group. The probability of recurrence was significantly lower in the MMC-BCG group than in the MMC-BCG/IFN group (43% vs 78% at 10 yr and 45% vs 80% at 15 yr, respectively; hazard ratio: 2.86; 95% confidence interval, 1.98-4.13; p<0.001). There were no significant differences in the probability of progression, disease-free mortality, or overall survival. CONCLUSIONS: Perioperative plus four weekly MMC instillations followed by monthly BCG, instead of alternating BCG and IFN-α2b instillations, significantly reduce long-term recurrence. PATIENT SUMMARY: We demonstrated in non-muscle-invasive bladder cancer patients with exceptionally frequent recurrences that the risk of long-term recurrence was reduced from 78-80% to 43-45% if one perioperative plus four weekly mitomycin C instillations were followed by monthly bacillus Calmette-Guérin (BCG) instillations for 1 yr instead of alternating instillations of BCG and interferon-α2b. TRIAL REGISTRATION: The registration was not considered necessary at this stage of the follow-up because the study was initiated as early as in 1992 and the last randomisation took place in 1996, before the current requirements concerning study registrations were implemented.

Long-term results of contact laser versus transurethral resection of the prostate in the treatment of benign prostatic hyperplasia with small or moderately enlarged prostates.

OBJECTIVE: To evaluate the long-term results of contact laser vaporization (CLV) of the prostate and transurethral resection of the prostate (TURP) in patients with symptomatic bladder outflow obstruction (BOO) caused by benign prostatic hyperplasia (BPH) with prostates smaller than 40 ml. MATERIAL AND METHODS: A total of 52 patients with lower urinary tract symptoms (LUTS) and urodynamically confirmed BOO caused by BPH with glands smaller than 40 ml were treated by means of CLV or TURP in a randomized trial. Changes in symptom score, urodynamics and prostate volume were evaluated during a 4-year follow-up period. RESULTS: A total of 42 (81%) of the patients were available for review at 4 years. The re-operation rate was 1/26 for each treatment. A sustained improvement in median Danish Prostate Symptom Score was seen in the laser group from 18 (range 5-54) to 5 (0-34) and in the TURP group from 18 (4-46) to 4 (0-18) (p<0.001 for both). A sustained improvement in maximum urinary flow rate was also seen in the laser group from 8.3 (4.8-19.6) ml/s to 14.3 (10.1-33.6) ml/s (p<0.001) and in the TURP group from 8.6 (5.0-15.9) ml/s to 16.1 (7.7-39.6) ml/s (p<0.01), without differences between the study groups. Median detrusor pressure at maximum urinary flow rate decreased significantly after both treatments, in the CLV group from 64 (32-112) cmH2O to 38 (18-65) cmH2O and in the TURP group from 57 (40-137) cmH2O to 28 (9-44) cmH2O (p<0.001 for both), and at 48 months was significantly higher in the laser group (p<0.01). At 4 years, 7/22 (32%) of the laser patients and 2/20 (10%) of the TURP patients were urodynamically obstructed. Post-void residual at 48 months was significantly lower in the TURP group than in the CLV group. Median prostate volume was smaller after TURP at 6 and 48 months (p<0.05). CONCLUSIONS: Long-term data of CLV and TURP treatments for BPH with small or moderately enlarged prostates indicate no significant difference in the relief of symptoms or in the rate of re-operations. However, the number of patients in this study was small and consequently the power to detect differences between the study groups was low. Regarding most objective outcome parameters, long-term follow-up revealed a slight advantage of TURP over CLV.

Sexual function of LUTS patients before and after neodymium laser prostatectomy and transurethral resection of prostate. A prospective, randomized trial.

OBJECTIVE: To assess and compare the sexual function of patients undergoing transurethral resection of the prostate (TURP) or Nd:YAG laser treatment for lower urinary tract symptoms (LUTS) caused by obstructing benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: 98 LUTS patients with urodynamically confirmed bladder outlet obstruction were recruited. Patients were randomised to TURP and laser treatment, which was further divided to contact and hybrid treatments according to prostate size. The sexual function at baseline and at 1 year postoperatively was assessed from the Danish Prostate Symptom Score Sexual Function Questionnaire (DanPSS Sex) items concerned with erectile stiffness, ejaculatory volume and pain or discomfort on ejaculation. RESULTS: The sexual function data at 1 year was available for 83 patients. At baseline, a high prevalence of erectile dysfunction (86%), ejaculatory volume change (83%) and pain or discomfort on ejaculation (26%) was observed and considered problematic by 79%, 63% and 100% of men, respectively. An increase of total impotence in the TURP group was observed (p = 0.046). TURP decreased or totally eradicated the amount of ejaculate, which was the only difference found between the study groups (p < 0.001). Both laser and TURP treatments improved pain or discomfort on ejaculation. CONCLUSIONS: The prevalence of sexual dysfunction in patients with symptomatic infravesical obstruction caused by BPH is high and perceived mostly as bothersome. TURP, Nd:YAG contact or hybrid laser treatments did not increase erectile dysfunction but improved pain or discomfort on ejaculation. The only significant difference between these treatments in respect to sexual function was a higher incidence of decreased or absent ejaculate after TURP.